Folic acid: uses, appearance and warnings

Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Folic Acid Tablets, USP, 1 mg , are supplied as Yellow colored round shaped biconvex uncoated tablet with " ET break line 28 " debossed on one side & plain on other side. They are available as follows: Bottles of 100: NDC 16571-881-01 Bottles of 1,000: NDC 16571-881-10 Dispense in well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 ° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Mfg. Lic no.: G/25/2258 Revised: 07/2026 PIR88110-00 US-057-00

Folic acid, USP is contraindicated in patients who have shown previous intolerance to the drug.

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. …

There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given. Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin. False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.